Home GUDID 08800021800175
XTG V
Primary DI 08800021800175
Brand XTG V
Company DigiMed Co., Ltd.
Model 1
Catalog number 1
Device description The devices is a hand-held diagnostic dental x-ray system. It is intended to be used by trained dentists and dental technicians as an extra-oral X-ray source producing diagnostic X-ray images using with intra-oral image receptors. Its use is intended for adults and pediatric subjects both. This device includes a high frequency inverter that changes direct current to alternating current, X-ray tube, electrical protective devices, and other elements. The system helps to get sharp and clear x-ray images, and its low radiation dosage keeps patients and dentists safe from leakage radiation.
Published 2026-06-01
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name EHD Unit, X-Ray, Extraoral With Timer
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EHD Unit, X-Ray, Extraoral With Timer Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 18800021800172 Package GS1 1 In Commercial Distribution 28800021800179 Package GS1 2 In Commercial Distribution 38800021800176 Package GS1 3 In Commercial Distribution 48800021800173 Package GS1 4 In Commercial Distribution 58800021800170 Package GS1 5 In Commercial Distribution 68800021800177 Package GS1 6 In Commercial Distribution 78800021800174 Package GS1 7 In Commercial Distribution 88800021800171 Package GS1 8 In Commercial Distribution 08800021800175 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 18800021800172 18800021800172 28800021800179 28800021800179 38800021800176 38800021800176 48800021800173 48800021800173 58800021800170 58800021800170 68800021800177 68800021800177 78800021800174 78800021800174 88800021800171 88800021800171 08800021800175 08800021800175 8800021800175
GMDN Terms# Term, Definition table Term Definition Hand-held intraoral dental x-ray system, digital A diagnostic dental x-ray system designed to generate and control x-ray beams. It records the absorption pattern of x-ray beams used for general-purpose, routine, dental radiography examinations involving the diagnosis and treatment (e.g., surgical or interventional) of diseases of the teeth, jaw and oral cavity structures. It is designed to be easily carried from location to location by a single operator. The sensor is placed in the mouth, the purpose being to visualize a limited region in detail. The data is either from analogue imaging and digitized afterwards or by digital imaging.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 0 0 Handling Environment Humidity 0 0 Handling Environment Temperature 0 0 Storage Environment Atmospheric Pressure 0 0 Storage Environment Humidity 0 0 Storage Environment Temperature 0 0
Regulatory Flags# DUNS number 688265810 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 08800021800168 XTG DigiMed Co., Ltd. EHD 2026-06-01 D090800047970 NOMAD Pro 3 X-Ray Tubehead, US Dental Imaging Technologies Corporation EHD 2026-03-31 D090800048750 NOMAD Pro 3 Packaged System, US Dental Imaging Technologies Corporation EHD 2026-03-31 D090800048870 NOMAD Pro 3 Packaged System, US Dental Imaging Technologies Corporation EHD 2026-03-31 08809840720046 WeRay PICOPACK Inc. EHD 2024-10-24 08800021800045 BIOX DigiMed Co., Ltd. EHD 2024-06-12 08800021800106 HYBRID S70 DigiMed Co., Ltd. EHD 2024-06-12 08800021800120 XTG PRO 70 DigiMed Co., Ltd. EHD 2024-06-12 08800021800137 DHX-70H DigiMed Co., Ltd. EHD 2024-06-12 07899581344695 EVOLVE SENSOR Alliage S/A Indústrias Médico Odontológica EHD 2023-12-08 07899581344701 EVOLVE SENSOR Alliage S/A Indústrias Médico Odontológica EHD 2023-12-08 07899581340253 Intraoral Dental Digital Imaging Sensor Alliage S/A Indústrias Médico Odontológica EHD 2023-10-18 07899581340260 Intraoral Dental Digital Imaging Sensor Alliage S/A Indústrias Médico Odontológica EHD 2023-10-18 07899581340284 Intraoral Dental Digital Imaging Sensor Alliage S/A Indústrias Médico Odontológica EHD 2023-10-18 07899581340697 Intraoral Dental Digital Imaging Sensor Alliage S/A Indústrias Médico Odontológica EHD 2023-10-18 07899581340727 Intraoral Dental Digital Imaging Sensor Alliage S/A Indústrias Médico Odontológica EHD 2023-10-18 08800021800113 xm-lite DigiMed Co., Ltd. EHD 2022-12-01 08800124900000 CLAROX VSI Co., Ltd. EHD 2022-07-25 08800072313211 Portable Dental X-ray (CS 2400P) NANORAY CO.,LTD EHD 2021-02-18 08800072313310 Portable Dental X-ray (CS 2300P) NANORAY CO.,LTD EHD 2021-02-18 08800072313419 Portable Dental X-ray (NR-F350 with Back scatter shield) NANORAY CO.,LTD EHD 2021-02-18 08800072313518 Portable Dental X-ray (R2 Port-X without Back scatter shield) NANORAY CO.,LTD EHD 2021-02-18 08800072313617 Portable Dental X-ray (R2 Port-X with Back scatter shield) NANORAY CO.,LTD EHD 2021-02-18 D7641000083061 XIOS AE SIRONA DENTAL, INC. EHD 2019-06-06 D7641000081680 XIOS AE SIRONA DENTAL, INC. EHD 2019-06-05 D7641000081790 XIOS AE SIRONA DENTAL, INC. EHD 2019-06-05 D7641000083480 XIOS AE SIRONA DENTAL, INC. EHD 2019-06-05 08800040900047 POSKOM Co., Ltd. Poskom Co., Ltd. EHD 2018-06-19 D7641000064510 Intraoral Sensor Wallbox SIRONA DENTAL, INC. EHD 2018-05-10 D7641000064561 Intraoral Sensor Wallbox SIRONA DENTAL, INC. EHD 2018-05-10